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Supplemental Filings: CBER/CDER Real-Time Comms, DCT Fall Off, Mifepristone REMS

Executive Summary

US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.

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